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Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Primary Purpose

Esophageal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
concurrent chemoradiotherapy plus DC-CIK immunotherapy
Concurrent chemoradiation only
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Locally advanced esophageal carcinoma, DC-CIK, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cytologically or histologically confirmed locally advanced esophageal carcinoma
  • Age: > 18
  • Karnofsky performance status ≥ 70
  • At least one measurable tumor lesions according to the RECIST criteria.
  • Normal functions of heart, lung, liver, kidney and bone marrow
  • Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
  • Informed consent signed

Exclusion Criteria:

  • Patients with metastatic disease in the central nervous system (CNS).
  • Patients who are pregnant or nursing.
  • Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
  • Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
  • coexisted morbidities that investigators believed not suitable for chemoradiation

Sites / Locations

  • Capital Medical University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

concurrent chemoradiotherapy plus DC-CIK immunotherapy

Concurrent chemoradiation only

Arm Description

patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy

patients will receive concurrent chemoradiotherapy only

Outcomes

Primary Outcome Measures

the quality of life

Secondary Outcome Measures

progression-free survival

Full Information

First Posted
September 17, 2012
Last Updated
January 2, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01691625
Brief Title
Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Official Title
Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
Locally advanced esophageal carcinoma, DC-CIK, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
concurrent chemoradiotherapy plus DC-CIK immunotherapy
Arm Type
Experimental
Arm Description
patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy
Arm Title
Concurrent chemoradiation only
Arm Type
Active Comparator
Arm Description
patients will receive concurrent chemoradiotherapy only
Intervention Type
Other
Intervention Name(s)
concurrent chemoradiotherapy plus DC-CIK immunotherapy
Intervention Description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation. DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.
Intervention Type
Other
Intervention Name(s)
Concurrent chemoradiation only
Intervention Description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.
Primary Outcome Measure Information:
Title
the quality of life
Time Frame
initial assessment, months 1, 3, 6 and 12
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Immunological assessment
Description
Cytokine secretion and T cell populations are assessed.
Time Frame
baseline, months 1, 3, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cytologically or histologically confirmed locally advanced esophageal carcinoma Age: > 18 Karnofsky performance status ≥ 70 At least one measurable tumor lesions according to the RECIST criteria. Normal functions of heart, lung, liver, kidney and bone marrow Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL Informed consent signed Exclusion Criteria: Patients with metastatic disease in the central nervous system (CNS). Patients who are pregnant or nursing. Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis coexisted morbidities that investigators believed not suitable for chemoradiation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ren, MD, PhD
Phone
86-10-63926317
Email
renjun9688@yahoo.com
Facility Information:
Facility Name
Capital Medical University Cancer Center
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD, PhD
Phone
86-10-63926317
Email
renjun9688@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

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